Manufacturer registered with FDA
Tomed GmbH
Köln, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name Tomed GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Tomed GmbH | 1 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Tomed GmbH | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Tomed GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | SOMNOGUARDSomnoGuard SP ProSomnoGuard SP SoftSomnoGuard SPXSomnoGuard® 2SomnoGuard® APSomnoGuard® AP 2SomnoGuard® AP PRO | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Tomed GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Tomed Dr. Toussaint GmbH (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Sep 2012 | K121761 | SOMNOGUARD SP SOFT | Tomed Dr. Toussaint GmbH | LRK Anti-Snoring Device |
| 8 Sep 2006 | K061688 | ANTI-SNORING / SLEEP APNEA DEVICE | Tomed Dr. Toussaint GmbH | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Tomed GmbHFDA reg. 3006038700 | Koeln North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9088701). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.